{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "196402",
      "product_res_number": "Z-0154-2023",
      "event_date_initiated": "2022-10-17",
      "event_date_posted": "2022-11-15",
      "recall_status": "Terminated",
      "event_date_terminated": "2024-09-17",
      "res_event_number": "90987",
      "product_code": "LZG",
      "k_numbers": [
        "K211575"
      ],
      "product_description": "18239: ASM Omnipod Dash PDM, insulin delivery system.  \nPT-000010: Assembly, Dash Final PDM U100, mg/dL\nPT-000011: Assembly, Dash Final PDM U100, mmol/L\nPT-000030: Assembly, DASH PDM, Canada\n\nRemote Controller (Personal Diabetes Manager or PDM) associated with Insulin Pump (Pod)\n\n\n*The part numbers above may be incorporated\ninto higher level assemblies such as DASH Starter\nKits.",
      "code_info": "Part Number/UDI-DI\n18239 : 10385082000009\nPT 000030: 10385082000122\nPT 000010: 10385082000139\nPT 000011: 10385082000146\n\nAll Serial Numbers and Lots",
      "firm_fei_number": "3014585508",
      "recalling_firm": "Insulet Corporation",
      "address_1": "100 Nagog Park",
      "city": "Acton",
      "state": "MA",
      "postal_code": "01720-3440",
      "additional_info_contact": "Insulet Customer Care\n800-641-2049",
      "reason_for_recall": "The firm has become aware of PDM battery issues, including battery swelling, fluid leaking from the battery, and extreme overheating, which may pose a fire hazard. The firm has received a complaint alleging fire as a result of thermal energy from a DASH PDM.",
      "root_cause_description": "Device Design",
      "action": "On October 17, 2022, the firm notified customers via Urgent Medical Device Correction letters sent via email. The firm followed up with physical mailers.\n\nCustomers will receive updated Omnipod DASH PDMs in the coming months. Customers do not need to call to receive an updated device, one will automatically be shipped to you when available.\n\nCustomers were provided with additional precautions to follow until they receive replacement units.\n\nIf you have any questions regarding the information provided in this Medical Device Correction, please visit our website at www.omnipod.com/insulet-alerts or call 1-800-641-2049 to speak with a dedicated staff member of the Insulet Customer Care team who will be available 24 hours a day, 7 days a week.",
      "product_quantity": "248,288 US; 167,802 OUS",
      "distribution_pattern": "Worldwide Distribution: US nationwide, Canada, Europe, Australia, and the Middle East.",
      "openfda": {
        "k_number": [
          "K160056",
          "K022831",
          "K030531",
          "K041318",
          "K042887",
          "K071613",
          "K021439",
          "K080639",
          "K111210",
          "K141758",
          "K032257",
          "K162296",
          "K253534",
          "K083225",
          "K143189",
          "K133593",
          "K111353",
          "K032164",
          "K960001",
          "K993012",
          "K192659",
          "K993184",
          "K031541",
          "K060876",
          "K142619",
          "K241622",
          "K093364",
          "K041317",
          "K994186",
          "K120206",
          "K053177",
          "K100567",
          "K050971",
          "K210714",
          "K070844",
          "K042873",
          "K963948",
          "K051041",
          "K990801",
          "K031373",
          "K972107",
          "K162080",
          "K073356",
          "K023471",
          "K082590",
          "K050760",
          "K063674",
          "K900498",
          "K062323",
          "K140439",
          "K180045",
          "K240158",
          "K013807",
          "K020655",
          "K160482",
          "K040676",
          "K071788",
          "K043000",
          "K131294",
          "K122483",
          "K111669",
          "K090245",
          "K082595",
          "K160252",
          "K001604",
          "K063126",
          "K211575",
          "K042792",
          "K901588",
          "K100504",
          "K013309",
          "K905693",
          "K103825",
          "K021725",
          "K991376",
          "K022317",
          "K973044",
          "K122953",
          "K182630",
          "K223372",
          "K022394",
          "K884978",
          "K050312",
          "K031738"
        ],
        "registration_number": [
          "3002806818",
          "3006479639",
          "3001058982",
          "3011393376",
          "3016540876",
          "3015218509",
          "3007007790",
          "3020976354",
          "3014585508",
          "3008824097",
          "3007981285",
          "3042027705",
          "9610126",
          "3009337401",
          "3006194679",
          "9617604",
          "3010162782",
          "3013756811",
          "3009515470",
          "3012421607",
          "3005340341",
          "9616814",
          "3007939342",
          "2032227",
          "3007710663",
          "3010047442",
          "3027453514",
          "1220477",
          "3008810357",
          "3013636348",
          "2246552",
          "2029275",
          "3005627859",
          "3007871880",
          "3010291427",
          "1313700",
          "1721676"
        ],
        "fei_number": [
          "3002806818",
          "3006479639",
          "3003166194",
          "3011393376",
          "3001058982",
          "3016540876",
          "3015218509",
          "3002558692",
          "3007007790",
          "3020976354",
          "3014585508",
          "3008824097",
          "3007981285",
          "3042027705",
          "3009337401",
          "3006194679",
          "3010162782",
          "3013756811",
          "1721676",
          "3009515470",
          "3012421607",
          "3005340341",
          "3007939342",
          "3004173703",
          "3010047442",
          "3027453514",
          "1220477",
          "3008810357",
          "3013636348",
          "1000306431",
          "2246552",
          "3005627859",
          "3007871880",
          "3010291427",
          "3003024060",
          "1313700",
          "3002806559"
        ],
        "device_name": "Pump, Infusion, Insulin",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5725",
        "device_class": "2"
      }
    }
  ]
}